Shoulder DislocationHYPSEMNCT04992598
Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management
A study testing Hypnosis session and Reduction in people with Shoulder Dislocation, run by Centre Hospitalier Régional Metz-Thionville at 7 sites in France.
Trial summary
The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine. Anteromedial dislocation is a very common Reason for admission in emergency department. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Dislocation
- What is being tested?
- Hypnosis session and Reduction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 7 sitesFrance
- Study dates
- 1 Jun 2024to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18 years and over,
- Checked into ED for an anterior shoulder dislocation suspected by clinical examination and confirmed by radiography,
- Had given oral consent to participate in the study
- Are affiliated or be a recipient of a social security plan.
- A staff member (nurse, nurse's aide, or physician) trained in hypnosis is available at the patient admission time.
Who cannot join
- Patient showing up with a shoulder fracture on x-ray.
- Patient presenting a shoulder prosthesis.
- Patient with recurrent dislocations.
- Patient who does not speak or understand French language.
- Patient with cognitive dysfunction.
- Patient with a psychiatric history of psychosis.
Show all 10Show fewer
- Patient who is deaf or hard of hearing.
- Patient under legal protection (guardianship, curatorship).
- Pregnant women
- Patient who already benefited of a pre-hospital reduction
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
France7 sites
CHR Fleyriat- Hôpital de Bourg en Bresse
Bourg-en-Bresse, Ain, 01000
Centre Hospitalier Saint Luc Saint Joseph
Lyon, Rhône, 69007
Groupement hospitalier Sud-Hôpital Lyon Sud
Lyon, Rhône, 69495
CHR Metz Thionville
Metz, Moselle, 57085
Hôpital Robert Pax
Sarreguemines, Moselle, 57200
Centre Hospitalier Lucien Hussel
Vienne, Isère, 38209
Hôpital Nord-Ouest Villefranche sur Saône
Villefranche-sur-Saône, Rhône, 69655
About this study
Official title: Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department
The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine.
Anteromedial dislocation is a very common Reason for admission in emergency department. Many methods for reduction have been described but there is no consensus on the optimum technique or sedation procedures.
Read more
Some pain medication and tranquilizers used during a shoulder dislocation management include hemodynamic, respiratory and behavioral adverse effects with the requirement of strengthened surveillance.
Hypnosis could provide to reduce sedative and analgesic use during the reduction of anteromedial dislocation.
The main objective of this study is to evaluate the efficacy of a hypnosis session for reducing the consumption of analgesic in patient throughout a reduction of shoulder dislocation.
The investigators also examine the effect of hypnosis on hemodynamic parameters, patient's pain, patient and practitioner satisfaction, sedative consumption, number of attempts for reduction and length of stay in the emergency department.
- Conditions
- Shoulder Dislocation
- Being tested
- Hypnosis session, Reduction
- Keywords
- Hypnosis
- Medical subject headings
- Shoulder Dislocation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypnosis sessionOther
Hypnosis session will precede therapeutic strategies and reduction
ReductionProcedure or surgery
All dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used.
| Study group | Role | What they receive |
|---|---|---|
| Hypnosis group | Experimental | Not described Receives: Other: Hypnosis session; Procedure: Reduction |
| Control group | Placebo comparator | Not described Receives: Procedure: Reduction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analgesic consumption
Calculated as the equal dose of morphine
Measured: Day 1
Secondary outcomes (7)
Dose of sedative drug
Dose of sedative drug
Measured: Day 1
Patients'satisfaction
Patients'satisfaction was assessed with a Likert scale after reduction. The satisfaction was scored on 5-point Likert scale, ranging from 1 to 5 (with 1=excellent and 5=catastrophic).
Measured: Day 1
Practitioners'satisfaction
Practitioners'satisfaction was assessed with a Likert scale after reduction. The satisfaction was scored on 5-point Likert scale, ranging from 1 to 5 ( with 1=excellent and 5=catastrophic).
Measured: Day 1
Number of attempts for reduction
Number of attempts for reduction
Measured: Day 1
Length of stay
Length of stay in the emergency department
Measured: Day 1
Method use for reduction
Method use for reduction
Measured: Day 1
Adverse events
number of adverse events
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Jun 2024 (estimated)
- Primary completion1 Jul 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Why it stopped: departure of the study coordinating investigator
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder DislocationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional Metz-Thionville
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04992598
- Sponsor's protocol ID
- 2021-02-CHRMT
- Acronym
- HYPSEM
- Status last verified
- May 2024
- First submitted
- 28 Jul 2021
- Last updated
- 30 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Tinelli M, Guler N, Goetz C, Aim P, Marchionni S, Ouamara N, Cipolat L, Demarquet M, Seris E, Moreau A, Durand G, Douplat M, Lavignon JP, Hingray C, Abensur Vuillaume L. Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol. BMJ Open. 2022 Dec 7;12(12):e062278. doi: 10.1136/bmjopen-2022-062278.
PubMed 36600368
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypnosis to Reduce Pain and Drugs for Shoulder Dislocation Management in the Emergency Department
- ClinicalTrials.gov ID
- NCT04992598
- Acronym / sponsor ID
- HYPSEM / 2021-02-CHRMT
- Conditions
- Shoulder Dislocation
- Keywords
- Hypnosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: departure of the study coordinating investigator
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional Metz-ThionvilleUniversity, hospital or other
- Study start
- 1 Jun 2024 (estimated)
- Primary completion
- 1 Jul 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The effectiveness of hypnosis for reducing pain was evaluated in various medical specialities. However, only few studies have demonstrated the efficacy of hypnosis for the management of pain in the emergency medicine.
Anteromedial dislocation is a very common Reason for admission in emergency department. Many methods for reduction have been described but there is no consensus on the optimum technique or sedation procedures.
Some pain medication and tranquilizers used during a shoulder dislocation management include hemodynamic, respiratory and behavioral adverse effects with the requirement of strengthened surveillance.
Hypnosis could provide to reduce sedative and analgesic use during the reduction of anteromedial dislocation.
The main objective of this study is to evaluate the efficacy of a hypnosis session for reducing the consumption of analgesic in patient throughout a reduction of shoulder dislocation.
The investigators also examine the effect of hypnosis on hemodynamic parameters, patient's pain, patient and practitioner satisfaction, sedative consumption, number of attempts for reduction and length of stay in the emergency department.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hypnosis group | Experimental | Other: Hypnosis session, Procedure: Reduction |
| Control group | Placebo comparator | Procedure: Reduction |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients aged 18 years and over,
- Checked into ED for an anterior shoulder dislocation suspected by clinical examination and confirmed by radiography,
- Had given oral consent to participate in the study
- Are affiliated or be a recipient of a social security plan.
- A staff member (nurse, nurse's aide, or physician) trained in hypnosis is available at the patient admission time.
Key exclusion criteria (10 listed)
- Patient showing up with a shoulder fracture on x-ray.
- Patient presenting a shoulder prosthesis.
- Patient with recurrent dislocations.
- Patient who does not speak or understand French language.
- Patient with cognitive dysfunction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypnosis sessionHypnosis session will precede therapeutic strategies and reduction | Other | Hypnosis group |
| ReductionAll dislocation would be reduced Under adequate analgesia and sufficient sedation. All methods for reduction can be used. | Procedure or surgery | Control group, Hypnosis group |
Primary outcome
Analgesic consumption
Time frame: Day 1
Calculated as the equal dose of morphine
7 secondary outcomes
Dose of sedative drug
Time frame: Day 1
Patients'satisfaction
Time frame: Day 1
Practitioners'satisfaction
Time frame: Day 1
Number of attempts for reduction
Time frame: Day 1
Length of stay
Time frame: Day 1
Method use for reduction
Time frame: Day 1
Adverse events
Time frame: Day 1
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2024.
- Derived from this study: PubMed 36600368Tinelli M, Guler N, Goetz C, Aim P, Marchionni S, Ouamara N, Cipolat L, Demarquet M, Seris E, Moreau A, Durand G, Douplat M, Lavignon JP, Hingray C, Abensur Vuillaume L. Study protocol: hypnosis versus standard care for shoulder dislocation reduction in the emergency department - a multicentre, randomised, controlled study protocol. BMJ Open. 2022 Dec 7;12(12):e062278. doi: 10.1136/bmjopen-2022-062278.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypnosis session and Reduction in people with Shoulder Dislocation, run by Centre Hospitalier Régional Metz-Thionville at 7 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 30 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesic consumption (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04992598, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2024.